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Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium (GCNI-CHC)

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ClinicalTrials.gov Identifier: NCT02799355
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital

Brief Summary:
Of the six main genotypes of the hepatitis C virus (HCV), genotypes 2 and 3 account for approximately 30% of chronic infections worldwide. In North India, Genotypes 3 and 1 account for 95% of chronic hepatitis C patients The first three direct-acting antiviral agents to receive FDA approval—boceprevir, telaprevir, and simeprevir—do not currently have a role in the treatment of genotype 3 infection. In contrast, the direct-acting antiviral agents, daclatasvir and sofosbuvir, have good activity against all genotypes. The SVR rates of 90 - 100% in genotype 3 were achieved with oral sofosbuvir plus ribavirin regimen to 24 weeks. Similar SVR rates were achieved in Genotype 1 with oral sofosbuvir plus weight based ribavirin and Pegylated Interferon alpha 2 a. However, the ongoing discovery and development of agents that directly target various stages of HCV replication are likely to provide HCV-infected patients with effective interferon-free therapy. HCV genotype 3 infection is associated with a higher incidence of hepatic steatosis, more rapid progression of fibrosis, and possibly a greater risk of hepatocellular carcinoma than is HCV genotype 2 infection.Moreover, patients with HCV genotype 3 infection are less responsive to peginterferon based treatment than are patients with HCV genotype 2 infection.

Condition or disease Intervention/treatment
Hepatitis, Chronic Drug: Sofosbuvir, Ribavirin, With or Without Pegylated Interferon

Detailed Description:
Sofosbuvir is an oral nucleotide analogue inhibitor of the HCV NS5B polymerase that is effective against HCV genotypes 2 and 3 when it is administered in combination with weight based ribavirin for 24 weeks. In Genotype 1, a combination of Pegylated Interferon alpha 2 a with oral Sofosbuvir and weight based Ribavirin for 12 weeks resulted in 90 -100 % sustained virological response rates (SVR). These SVR rates for chronic hepatitis C genotypes 1,2 and 3 are all based on Western studies. The investigators plan to conduct a retrospective study in Northern India region on patients treated with Sofosbuvir and Ribavirin or Sofosbuvir, Ribavirin and Peginterferon alpha 2a. The purpose of the investigators study is to assess the percentage of patients with sustained virologic response.

Study Type : Observational
Actual Enrollment : 1203 participants
Time Perspective: Retrospective
Official Title: Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium
Study Start Date : May 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Sofosbuvir, Ribavirin, With or Without Pegylated Interferon
    Retrospective will carried out to find percentage of patients with sustained virologic response at 12 weeks after the end of treatment
    Other Name: Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon


Primary Outcome Measures :
  1. Proportion of patients with sustained virologic response at 12 weeks after the end of treatment. [ Time Frame: 3 month ]
    Sustained virologic response was defined as a level of HCV RNA below the lower limit of quantification (25 IU per milliliter)


Secondary Outcome Measures :
  1. Side effect [ Time Frame: 3 month ]
    Assess the treatment side effect



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study is a retrospective study conducted on 1500 to 2000 patients who have recieved treatment of Sofosbuvir and Ribavirin or Sofosbuvir, Ribavirin and peg interferon alpha 2a
Criteria

Inclusion Criteria:

  • Age more then 18 years.
  • Patient who on treatment of either Sofosbuvir and Ribavirin (24 weeks) or Sofosbuvir, Ribavirin and peginterferon (12 weeks).

Exclusion Criteria:

  • Patient who are lost to follow up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799355


Locations
India
Department of Gastroenterology, D.M.C. and Hospital
Ludhiana, Punjab, India, 141001
Sponsors and Collaborators
Dayanand Medical College and Hospital

Publications of Results:

Responsible Party: Prof. Sandeep S Sidhu, Professor, Dayanand Medical College and Hospital
ClinicalTrials.gov Identifier: NCT02799355     History of Changes
Other Study ID Numbers: GCNI-CHC
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Interferons
Ribavirin
Sofosbuvir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action